COMFIT BLUE POWDER FREE EXAMINATION GLOVES

Latex Patient Examination Glove

WEMBLEY RUBBER PRODUCTS (M) SDN BHD

The following data is part of a premarket notification filed by Wembley Rubber Products (m) Sdn Bhd with the FDA for Comfit Blue Powder Free Examination Gloves.

Pre-market Notification Details

Device IDK943563
510k NumberK943563
Device Name:COMFIT BLUE POWDER FREE EXAMINATION GLOVES
ClassificationLatex Patient Examination Glove
Applicant WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor,  MY 43900
ContactOng Ghee Chee
CorrespondentOng Ghee Chee
WEMBLEY RUBBER PRODUCTS (M) SDN BHD KAWASAN PERUSAHAAN BANDAR BARU LOT 1, JALAN 3 Sepang Selangor,  MY 43900
Product CodeLYY  
CFR Regulation Number880.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-22
Decision Date1995-03-07

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